Senior Scientist/Associate Principal Scientist, Cell Therapy Clinical Pharmacologist
Core
Lead clinical pharmacology strategies for novel cell therapy programs (CAR-T, TCE) by designing studies, performing PK/PD analyses, and optimizing dosing to minimize toxicities like CRS.
Role type
Senior IC clinical pharmacologist (cell therapy)
Builds
Clinical study protocols, Investigator's Brochures, Clinical Study Reports, regulatory briefing documents, and PK/PD risk/benefit profiles.
Domain
Biopharmaceuticals / Cell Therapy / Clinical Pharmacology
Required skills
Clinical pharmacology study design, PK/PD analysis (non-compartmental, population modeling), regulatory document authoring, cross-functional team leadership, dose selection strategy, toxicology risk assessment
Preferred skills
Population PK/PD or PBPK modeling, biomarker data interpretation (cytokines, flow cytometry), experience with novel modalities (Bi-specific Antibody, T cell engager), CRO management
Technologies
Phoenix WinNonlin, R, NONMEM
Responsibilities
Lead design and execution of Phase I/IIT clinical pharmacology studies; Develop short-to-medium-term CP plans; Author core clinical documents (protocols, IB, CSR); Perform advanced PK/PD analyses; Synthesize PK/PD results for study teams and leadership; Lead regulatory briefing preparations; Establish departmental best practices and SOPs
Seniority
Senior, hands-on IC